Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs, as well as Generics Bulletin Executive Editor David Wallace, consider the implications of the US Supreme Court decision upholding the skinny labeling system (:37), including how the generic industry will adapt going forward (9:02). They also discuss the stakeholder comments the US Food and Drug Administration received during a public hearing on the National Priority Voucher and their potential impact on the program’s future (10:50).
More On These Topics From The Pink Sheet
US Supreme Court Retains Skinny Labeling System, Backs Hikma
Over Amarin: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-supreme-court-retains-skinny-labeling-system-backs-hikma-over-amarin-4LH4TCR2OVHPBPVMUTN4HGRQCE/
Stakeholders Want Clearer Eligibility Criteria For US FDA’s
National Priority Voucher Program: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/stakeholders-want-clearer-eligibility-criteria-for-us-fdas-national-priority-voucher-program-LWGMZFB3VZAUHOZIRCPFWH4JCU/
NPV Program Facing Legal Durability Questions As Public
Meeting Impacting Its Future Approaches: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/cnpv-program-facing-legal-durability-questions-amid-loper-bright-decision-YUZ6E4VAJZFYBOEWMRSWRSRAFI/
Grading US FDA’s National Priority Voucher Program After One
Year: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/grading-us-fdas-national-priority-voucher-program-after-one-year-UXYNFYXDGFFH7L6WXG7TMRZPEQ/
CNPV Public Meeting Questions: US FDA Seeks Talking Points
Before Confirming Speakers: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/cnpv-public-meeting-questions-us-fda-seeks-talking-points-before-confirming-speakers-NOZ3QRCLZZCI5K7EXYWKKP7PFY/